Kornimate/medical-research-clean huggingface dataset:
rifaximin and placebo in the treatment of bowel dysfunction after anterior resection for rectal cancer

Conditions: Rectal Cancer

Summary: the most common long-term problems after rectal surgery are bowel problems. these problems can include needing to pass bowel movements a lot, loose or mushy stools, inability to fully clear your bowels, and/or poor control of gas and stool. the investigators believe that a major cause of these problems is too much bacteria in the bowel and treatment with antibiotic tablets will hopefully help improve these bowel problems. in order to test this idea, the colorectal surgery service of memorial sloan kettering cancer center is sponsoring a clinical trial. this trial will compare the antibiotic rifaximin and a placebo (a harmless tablet that has no effect) in the treatment of these bowel problems. following this we will attempt to see if another antibiotic metronidazole also helps to treat these bowel problems. both metronidazole and rifaximin are well established drugs that have minimal side effects.


Eligibility criteria:
inclusion criteria: * patients with a history of rectal cancer treated with an anterior resection preformed at mskcc (tumor at or below 12cm from anal verge) with restoration of bowel continuity ≥1 and ≤ 5 years. (patients may also have had procedures to construct neo-rectums including j-pouch, coloplasty, and end to side anastomosis). * patients ≥ 21 years of age. * presence of anterior resection symptoms by patients own assessment. these symptoms may include any of the following: incomplete evacuation, clustering of bowel motions, frequency of bowel motions, unformed stool, excessive flatus, or incontinence of flatus and/or feces. exclusion criteria: * local recurrence of rectal cancer. * antibiotic treatment within the last 4 weeks for any condition. * pregnancy or breast feeding.

Keywords: rectal colon placebo rifaximin metronidazole 11-045
supplemental nursing system compared to bottle supplementation

Conditions: Breast Feeding, Exclusive

Summary: this is a randomized controlled trial comparing the sns to bottle feeding. this study will compare exclusive breastfeeding rates and breast milk feeding rates at discharge, day of life 14, and day of life 28 between neonates hospitalized in the nicu for hyperbilirubinemia between those who receive supplementation by the (sns) or those who receive supplementation by bottle. additionally, this study will evaluate mothers' experiences while using the sns. we hypothesize mothers who utilize the sns will have higher rates of breast milk feeding compared to mothers who supplement by bottle.

supplemental feedings in the neonatal intensive care unit (nicu) are common due to the separation of mother and neonate and/or complex medical issues that make direct breastfeeding difficult. the supplemental nursing system (sns) is utilized infrequently in the nicu and there is little data available to compare breastfeeding outcomes of mothers who supplement by bottle compared to sns. the aims of this study are to understand whether supplementation by sns improves breastfeeding outcomes compared to neonates supplemented by bottle. from december 1, 2018 - november 30, 2019 there were 195 neonates admitted to children's hospital colorado (chco) with a primary diagnosis of hyperbilirubinemia who were born at 37 weeks or greater. this makes up approximately 13.7% of all admissions during that time frame. this is a population of mothers at risk for cessation of exclusive breastfeeding due to the necessity of supplementation. these neonates are frequently supplemented because the mother's milk typically is not yet in to support adequate nutritional intake. these neonates are not often medically complex or have any factors that would bias the results of this study.

Eligibility criteria:
inclusion criteria: * neonate inclusion criteria: physician diagnosis of hyperbilirubinemia, otherwise healthy term neonates (gestational age 38 weeks +), appropriate size for gestation, and good latch to mother's nipple, with some consistent suckling behavior per standard assessment. maternal inclusion criteria: english or spanish speaking (with the use of medical interpreter), 18 years of age or greater, desire to exclusively breast milk feed, and must be available at the bedside for all feeding sessions during hospitalization. exclusion criteria: * neonate exclusion criteria: breast milk jaundice, and any condition that prevents the neonate from breastfeeding efficiently including anatomical abnormalities (cleft lip, cleft palate), neurological impairment, symptomatic hypoglycemia, newly diagnosed infections, cardiac anomalies, and intravenous fluid hydration. maternal exclusion criteria: retained placenta, history of breast reduction surgery or breast radiation, physician diagnosed sheehan's syndrome, known hypoplastic breast tissue with a low supply after previous deliveries.

Keywords: supplemental nursing system
ambulatory medication reconciliation following hospital discharge

Conditions: Medication Administered in Error; Adverse Drug Events

Summary: adverse drug events (ades) after hospital discharge are common. the purpose of this research study is see if we can design an electronic tool given to your primary care provider (pcp) that will reduce adverse drug events, hospital readmissions, and emergency department visits after you are discharged from the hospital.

the objective of this research is to reduce the incidence of post-discharge medication discrepancies, preventable and ameliorable ades, hospital readmissions, and ed visits through the use of hit. the proposed tool will prompt primary care physicians to perform medication reconciliation at the first post-discharge outpatient visit, clearly display and organize preadmission and discharge medication regimens, and facilitate the creation of the new post-discharge medication list with just a few keystrokes. using methodologies from prior studies at bwh, we will evaluate the intervention in a two-site rct. the study will be conducted at brigham and women's hospital and massachusetts general hospital, taking advantage of our rich experience with designing and testing new informatics applications, including one for inpatient medication reconciliation.

Eligibility criteria:
inclusion criteria: * patients admitted to bwh or mgh who plan to follow up with a pcp in one of 12 primary care practices affiliated with bwh or mgh. * patients will need to meet the following criteria: * 1) be 55 years or older, * 2) be admitted to the participating delivery system's hospital during the study period for a non-psychiatric condition, * 3) have no plans to enter hospice, * 4) be discharged back to the community, * 5) be prescribed 5 or more medications at discharge, including at least one of the following: * antibiotics, * insulin, * antihypertensives, * anti-rejection, * antiarrhythmics, * inhalers, * antiepileptics, * antianginals, * pain medications, * oral hypoglycemics, * steroids, * anticoagulants. * these drugs were selected because they require close monitoring, increase risk for drug-drug interactions, have a narrow therapeutic window, or are known to increase risk for ades in the older adult population exclusion criteria: unable to provide informed consent and has no proxy who administers patient's medications and can provide informed consent

Keywords: adverse drug events outpatient
efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on the patients with newly diagnosed type 2 diabetes mellitus combined with non-alcoholic fatty liver disease

Conditions: Type 2 Diabetes Mellitus; Non-alcoholic Fatty Liver Disease; Efficacy

Summary: this is an multicenter, randomized, double-blind, parallel-controlled study to evaluated the efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on the patients with newly diagnosed type 2 diabetes mellitus combined with non-alcoholic fatty liver disease.

taking metformin monotherapy as a control, we evaluated the efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on hepatic fat ultrasound and liver enzyme levels, and observed whether the drug can improve fatty liver in patients with newly diagnosed type 2 diabetes combined with non-alcoholic fatty liver disease. this is an multicenter, randomized, double-blind, parallel-controlled study.

Eligibility criteria:
inclusion criteria: 1. to meet the new diagnosed type 2 diabetes patients, never received oral hypoglycemic drugs or insulin therapy; 2. in accordance with the nonalcoholic fatty liver (nafld) criteria for the diagnosis of patients. 3. the level of hba1c was 7 -10.0%; 4. age 18-70, body mass index 21-35kg/m2; 5. the subjects informed consent and signed the informed consent. exclusion criteria: 1. type 1 diabetes or secondary diabetes; 2. suffering from other liver diseases, such as hepatitis, self - free liver, etc. 3. abnormal thyroid function (in the active period), or the need for long-term oral and intravenous glucocorticoids to treat patients; 4. patients with severe renal dysfunction or renal disease (egfr\<60); 5. in those with abnormal liver function, alanine transaminase(alt) or aspartate transaminase(ast) was more than 3 times the normal upper limit. 6. people with serious gastrointestinal diseases such as peptic ulcers and chronic diarrhea; 7. patients with severe cardiopulmonary disease, cerebrovascular disease or stents; 8. hemopoietic system diseases such as serious primary diseases, hemoglobin \< 100g/l or need regular transfusion treatment; 9. pregnant, breast-feeding, women of childbearing age who are unwilling to contraception during the study period; 10. chronic cardiac insufficiency, the classification of heart function iii level and above; 11. uncontrolled malignant tumor, and the history of bladder cancer. 12. acute complications of diabetes; 13. the use of other drugs for diabetes and liver disease; 14. patients who had participated in other clinical studies within three months; 15. people who have known allergies to this kind of drugs are known. 16. it is impossible to guarantee the effect or the safety judgment of the drug or the person who is unable to cooperate with the mental illness.

Keywords: type 2 diabetes mellitus pioglitazone hydrochloride and metformin hydrochloride tablets randomized controlled trial non-alcoholic fatty liver disease
who-hph recognition project on fast-track implementation of clinical health promotion

Conditions: Smoking; Excessive Drinking; Lack of Physical Activity; Malnutrition; Obesity

Summary: the project's background is the notion that patient centred clinical health promotion has been shown to significantly improve both outcomes and patient safety. accordingly, the who describes health promotion as a key dimension of quality in hospitals, and the organization has developed standards on the topic in order to help hospital management and staff members to assess and improve the quality of health care and thereby achieve better health for patients, staff, and community. even so, however, health promotion is still a very implicit part of nearly all quality standards on hospitals. moreover, assessing hospitals departments' health promotion performance is still quite an unexplored area. on this basis, this project will test a new recognition process that uses the relevant who-hph tools and standards to assess performance, by way of explicit documentation and evaluation of clinical health promotion activity. the project is deigned as a rct, with a control group that undergoes the recognition process immediately and a control group that continue usual clinical routine. then, after one year, the control group also begins the recognition process (= delayed start), while the intervention group (=immediate-start) continues with the recognition process. doing this allows for a great array of measurements, and hopefully the project will then show whether the recognition process really benefits implementation of health promotion in hospitals and health services, and also, if this really generates better health gains for patients and staff. the outcome measurements will be frequency of health promotion services delivered on smoking, excessive alcohol use, overweight, malnutrition, and physical activity to patients in need. such services could for instance be motivational counselling and brief interventions, as well as intervention, rehabilitation and after treatment. physical, mental, and social health status among patients and staff will be measured by short form (sf36).


Eligibility criteria:
inclusion criteria: * clinical hospital departments from university hospitals * clinical hospital departments from non-university hospitals exclusion criteria: * palliative care departments * pediatric departments * nursing homes * non-hospital departments * primary care facilities

Keywords: recognition process health promotion hph who hospitals health services health gain service delivery quality management
participation in competing strategies for colorectal cancer screening - a randomized health services study within the national screening program in poland

Conditions: Colorectal Cancer

Summary: the piccolino is a randomized health services study performed within the framework of the polish colonoscopy screening program (pcsp) in poland. within the study 12,298 eligible persons between 55 and 64 years of age will be drawn from the population registry and randomly assigned in a 1:1:1 ratio to receive an invitation to participate in one of the three screening strategies: (i) postal invitation to colonoscopy and a re-invitation to colonoscopy for initial non-responders, (ii) postal invitation for screening using fecal immunochemical test (fit) for non-responders and subjects refusing a colonoscopy, or (iii) postal invitation offering a choice between fit and colonoscopy. colonoscopies will be performed in seven local centers participating in the study. fits will be analyzed in the central laboratory. subjects with positive fit result will be recommended to undergo colonoscopy. the primary outcome is participation with crc screening within 18 weeks after enrollment, defined as completion of colonoscopy, or completion of fit along with colonoscopy for positive fit result. secondary outcome will be diagnostic yield for advanced neoplasia (crc or advanced adenoma). the study has been approved by a local bioethics committee.


Eligibility criteria:
inclusion criteria: men and women aged 55 to 64 years residing in poland and assigned to be invited to screening within the polish colonoscopy screening program . exclusion criteria: * information of a selected subject death informed by family, neighbors or post office that has not been included in the personal identity number (pesel) system. * addressees of letters that have been returned by the post office. * subjects requiring long-term care due to somatic, psychosocial reasons or with mental disability. * history of colorectal resection.

Keywords: colorectal cancer screening
study of maternal hepatitis c infection and influenza vaccination in pregnancy

Conditions: Hepatitis C

Summary: the purpose of this study is to determine if hepatitis c virus and influenza virus vaccine components can cross the placenta and stimulate an immune response in the fetus.

the rate of mother-to-child transmission of hepatitis c virus (hcv) is only 5%, even though the level of fetal exposure to the virus during pregnancy is probably much higher. how can the fetus avoid infection in so many cases? we believe the fetal immune system is not immature as has previously been thought, but instead plays an active role in protecting the fetus from infection. in this study, we aim to better understand the immune response of the fetus against maternal hcv infection. in addition, since the fetus has been shown in some cases to make an immune response against vaccines given to the mother during pregnancy, we also aim to study the fetal immune response against maternal influenza virus vaccination. we plan to study 50 hcv-positive pregnant women and their infants (study group) and compare them to 20 hcv-negative pregnant women and their infants (control group). we estimate that approximately 30 women in the study group will have received the influenza virus vaccine. we will analyze 3 important components of mother-to-child transmission: (1) the maternal immune response against hcv and influenza virus vaccine during and after pregnancy; (2) the baby's immune response to these agents at birth, 9-15 months, and 24 months; and (3) the placenta, for the presence of hcv particles or influenza virus vaccine components. the results of this study may have implications for the prevention of mother-to-child transmission of hcv and other infections, as well as for the development of novel vaccination strategies.

Eligibility criteria:
inclusion criteria: * pregnant women 18 years of age or older * infants born to these women from this pregnancy * hepatitis c virus antibody and rna positive (for study group) * hepatitis c virus antibody and rna negative (for control group) exclusion criteria: * hiv infection * hepatitis b infection * plan to use cord blood for another purpose

Keywords: pregnancy immunity cord blood influenza vaccines disease transmission, vertical
jnt versus tnt to guided ogt-overlap oesophagojejunostomy

Conditions: Gastric/Gastroesophageal Junction (g/Gej) Cancer

Summary: gastric/gastroesophageal junction (g/gej) cancer patients who underwent laparoscopic total gastrectomy (ltg) were eligible for this study

all patients enrolled in our study underwent standard laparoscopic total gastrectomy (ltg) with d2 lymphadenectomy and ogt-overlap oesophagojejunostomy according to the japanese gastric cancer association treatment guidelines and our previous reports. when the surgeons decided to perform ogt-overlap oesophagojejunostomy after gastrectomy, we randomised the patients into the traditional decompression nasogastric tube (tnt) group or joint nasogastric tube (jnt) group by simple randomization operatively. in the tnt group, the tnt was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophagealstump . while in the jnt group, the jnt was used to substitute the tnt. after the anastomosis was completed, the team of surgeons performed an intraoperative gastroscopy to check for defects, bleeding, and stenosis in the anastomosis, and esophageal pseudocanals, and also to confirm whether the esophageal mucosa was damaged by tnt or jnt.

Eligibility criteria:
inclusion criteria: (1) age 18-75 years; (2) physical status score (ecog) 0-2 points; (3) preoperative pathological examination to diagnose gastric/gastroesophageal junction (g/gej) cancer; (4)no obvious contraindications for surgery; (5)did not found metastasis preoperatively and intraoperatively; (6)confirmed tumours invade oesophagus no more than 3cm intraoperatively; (7) expected to perform ogt-overlap oesophagojejunostomy after lymphadenectomy and gastrectomy in the operation of laparoscopic total gastrectomy. exclusion criteria: (1)underwent radiotherapy for g/gej cancer preoperatively; (2) continuous hipec after operation.

Keywords: gastric tumor gastric/gastroesophageal junction (g/gej) laparoscopic total gastrectomy overlap anastomosis joint nasogastric tube
remifentanil intravenous patient controlled analgesia (ivpca) for ablation of idiopathic ventricular tachycardia

Conditions: Tachycardia, Ventricular

Summary: determine effects of remifentanil conscious sedation in patients undergoing electrophysiological (ep) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent premature ventricular contractions (pvcs) of non-ischemic origin

the purpose of the study is to determine the effects of remifentanil conscious sedation in patients undergoing electrophysiological (ep) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent pvcs of non-ischemic origin. remifentanil is an analgesic- synthetic opiate with an very short half life. it is rapidly broken down by enzymes in the blood and is ideally suited for continuous sedation. the effect is practically eliminated within 5 minutes after the intravenous sedation is stopped. you are being asked to participate in this study because you are already scheduled to undergo ep studies under the care of your cardiologist for the ablation of idiopathic ventricular tachycardia and/or persistent frequent pvcs of non-ischemic origin.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo ep studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent pvcs of non-ischemic origin * patients between 18 and 65 * asa 1-3 exclusion criteria: * asa 4 and 5 * age 18 and 65

Keywords: idiopathic ventricular tachycardia
increasing decision quality for men with lower urinary tract symptoms

Conditions: Patient Engagement; Patient Preference

Summary: in this study, the investigators show that by upskilling of primary care physicians (pcps) in sdm and leveraging on a novel pictorial visual analogue uroflowmetry score (vaus), they can enhance older men's recognition of luts and stimulated discussion with their pcps.

lower urinary tract symptoms (luts), often related to prostatomegaly, is common but seldom sought medical attention amongst older men. visual-aid and shared decision-making (sdm) are potential solutions to address luts. the study aimed to determine the effect of a novel pictorial visual analogue uroflowmetry score (vaus) and primary care physicians (pcp) sdm training on the decisional quality amongst men selecting their treatment options for luts. this study recruited 60 multi-ethnic asian men aged ≥50 years with moderate-to-severe luts (international prostate symptoms score≥8 and/or qol≥3) in a singapore public primary care clinic. men used the vaus to report their symptoms. 60 men were randomly assigned to pcps trained in sdm in the intervention group (n=30) and the other 30 to the control group (pcps without sdm-training). patient-physician dyad decision quality was measured using the validated sdmq-9 (patient) and sdmq-doc (physician) questionnaires.

Eligibility criteria:
inclusion criteria: * men aged 50 years old and older attending the polyclinic for routine follow up of a chronic disease (non-communicable disease) * have moderate-to-severe luts and/or poor quality of life (qol) as assessed by the validated international prostate symptom score (ipss) of eight or more and/or its individual qol score of three or more * men of any local asian ethnicity and were willing to provide written consent * can communicate with their allocated pcp in either of the three main local languages; english, mandarin or malay. exclusion criteria: * have indwelling catheters * urinary incontinence requiring diapers * anuria due to any renal pathology * gross hematuria * acute urinary retention * symptoms consistent with an acute urinary tract infection * existing treatment of luts or other prostate pathology * visual or hearing impairment which render men incapable of understanding the study procedure and providing informed consent * men unwilling to discuss their luts treatment options with their pcp